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FDA 510(k)

PLAMP, PLAMP PLATE, PLAMP WITH HOOK

K-Number: K942032 · 1996-06-13

ApplicantHospital For Special Surgery
Decision Date1996-06-13
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

PLAMP, PLAMP PLATE, PLAMP WITH HOOK is the device name listed in this FDA 510(k) record. The listed applicant is Hospital For Special Surgery. It received FDA 510(k) clearance on 1996-06-13 under 510(k) number K942032. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the PLAMP, PLAMP PLATE, PLAMP WITH HOOK?

PLAMP, PLAMP PLATE, PLAMP WITH HOOK is a medical device that received FDA 510(k) clearance on 1996-06-13. The listed applicant is Hospital For Special Surgery. The 510(k) number is K942032.

When did PLAMP, PLAMP PLATE, PLAMP WITH HOOK receive FDA 510(k) clearance?

PLAMP, PLAMP PLATE, PLAMP WITH HOOK received FDA 510(k) clearance on 1996-06-13, under 510(k) number K942032.

Who is the listed applicant for PLAMP, PLAMP PLATE, PLAMP WITH HOOK?

The FDA 510(k) record lists Hospital For Special Surgery as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLAMP, PLAMP PLATE, PLAMP WITH HOOK?

The FDA product code for PLAMP, PLAMP PLATE, PLAMP WITH HOOK is HRS.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Hospital For Special Surgery as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K934857HSS FEMORAL COMPONENTSK935080INSALL-BURSTEIN II

Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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